Hepatocellular Carcinoma
Conditions
Keywords
HCC
Brief summary
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC). The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.
Detailed description
Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of HCC. This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events.
Interventions
DRUGAG-013736
All enrolled patients will receive axitinib, 5 mg orally twice daily with food, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
Sponsors
Tri-Service General Hospital
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically diagnosed HCC, OR clinically diagnosed HCC * Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy * Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC * At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure * ECOG performance status 0 or 1 * Life expectancy is at least 2 months * Child-Pugh class A liver function.
Exclusion criteria
* Systemic therapy other than sorafenib as first-line therapy for advanced HCC * History of HCC tumor rupture * Presence of brain or leptomeningeal metastases * Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding * History of upper gastrointestinal bleeding within 1 year * Major systemic diseases that the investigator considers inappropriate for participation * Uncontrollable hypertension * Proteinuria * Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers * Requirement of anticoagulant therapy with oral vitamin K antagonists * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease stabilization | 8 weeks until tumor progression |
Secondary
| Measure | Time frame |
|---|---|
| time-to-tumor progression | 8 weeks until tumor progression |
Countries
Taiwan
Outcome results
None listed